Regulatory Information Management

The Life Sciences regulatory and business environment is complex and constantly evolving. Our holistic RIM platform offers a streamlined approach that enables Life Sciences companies to achieve long term business benefits beyond compliance.

A streamlined approach across all stages of product development life cycle

Amplexor Regulatory Information Management (RIM) solutions enable life sciences companies to drive, manage and control the processes of releasing new products or maintaining existing products on the market: 

  • Managing information throughout the products lifecycle
  • Planning and tracking regulatory activities
  • Managing interactions with health authorities and other regulatory bodies
  • Overseeing the authoring, reviewing and approving of submission documents
  • Supporting global label management processes
  • Planning, compiling, reviewing, publishing, submitting and managing submissions
  • Managing product data and content in line with the IDMP target operating model (TOM)

Our RIM Products

Benefits

End-to-end support

A holistic solution which supports end-to-end business processes

Centralized information

A common master data model providing a solid foundation for a single source of truth

Reusable data

Reusable data and content across all solutions and processes

Powerful automations

Decrease manual steps, reduce data entry and increase data quality

Increased efficiency

An increased level of efficiency, enterprise-wide standardization and collaboration

Quality & compliance

Lower complexity, higher overall quality of medicinal products, and sustainable compliance

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